BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHEUMATOID FACTOR

    MDR report key: 2008334 · Received March 6, 2011

    Report

    Report Number
    2050012-2011-00663
    Event Type
    Malfunction
    Date Received
    March 6, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS PLASMA. PER CUSTOMER, CALIBRATION AND QC RESULT ARE NORMAL. CUSTOMER DID NOT REPORT INSTRUMENT ISSUES OR PROBLEMS WITH OTHER CHEMISTRIES. CUSTOMER WAS RUNNING RF REAGENT LOT M007324 AND CALIBRATOR LOT M905541. THE SYSTEM HAD BEEN RECENTLY SERVICED AND THAT THIS HAD NOT RESOLVED THE ISSUE SERVICE WAS NOT DISPATCHED SINCE THIS IS A REAGENT ISSUE. CUSTOMER TECHNICAL SUPPORT SENT A NEW LOT OF CALIBRATOR, AND CUSTOMER INDICATED RESULTS WERE ACCEPTABLE WITH THIS CALIBRATOR CHANGING REAGENT LOTS HAS RESOLVED THE ISSUE. NO ADDITIONAL SERVICE WAS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS HIGH RHEUMATOID FACTOR RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY THE INITIAL SAMPLE WAS SENT OUT TO A REFERENCE LAB FOR REPEAT TESTING AND LOWER RESULT WAS OBTAINED. NO IMPACT TO PATIENT OR TO PATIENT TREATMENT OCCURRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEUMATOID FACTOR RHEUMATOID FACTOR, DHR BECKMAN COULTER INC. RHEUMATOID FACTOR M007324/M905541

    Patients

    Seq Age Sex Outcome Treatment
    1